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Truvada (emtricitabine/tenofovir disoproxil fumarate), an antiretrovial approved by the FDA in 2012 for preventing sexual transmission of HIV has made recent headlines in the popular media (here, here, and here). According to a recent report on npr.org, a homosexual man felt stigmatized by his emergency medicine physician when she found out he was on the drug. This story highlighted something that I’d been thinking about since I first heard about Truvada this past spring. I’ve been wondering what place, if any, Truvada has in emergency medicine?What is Truvada?Truvada is composed of tenofovir and emtricitabine, two antiretroviral HIV medications. It is recommended for use as a Pre-Exposure Prophylaxsis (PrEP) for people who do not have HIV but are at significant risk of developing HIV. It had previously been approved for use in combination with other antiretrovirals to treat HIV positive adults and children greater than 12 years old. To be clear Truvada does not fully prevent infection but it does reduce the risk of acquiring HIV. Currently Truvada is the only FDA approved medication for PrEP.

The Evidence In the iPrEx study, published in the NEJM, gay and transgender men who took Truvada vs placebo were 44% less likely to get HIV (95% CI, 15 to 63; P=0.005). Blood levels of the medication correlated with prophylactic effect. In patients with a detectable study-drug level, the odds of HIV infection was decreased by 12.9% (95% CI, 1.7 to 99.3; P<0.001). This corresponded to a relative risk reduction of 92% (95% CI, 40 to 99; P<0.001) (1).In a randomized control trial of 1219 men and women in Botswana, patients given Truvada as opposed to placebo had a 62% reduced risk of contracting HIV (95% CI, 21.5 to 83.4; P=0.03). Again, patients who had lower blood levels of the medication were at higher risk of developing an infection (2).In a randomized trial of heterosexual couples in a discordant relationship (one partner is HIV positive while the other is HIV negative), couples given Truvada (emtricitabine/tenofovir) versus only tenofovir had a 75% risk reduction (95% CI, 55 to 87, p<0.001) in developing HIV-1 (3).A Cochrane Review in 2012 determined that PrEP with Truvada resulted in a relative risk reduction of 0.51 (95% CI 0.30 to 0.86) of contracting HIV when compared to a placebo. A relative risk reduction was also seen in patients treated with only tenofovir but it was not as significant as with combo therapy (RR 0.38; 95% CI 0.23 to 0.63) (4).Target Patient PopulationAccording to the CDC, new federal guidelines recommend that PrEP be considered in anyone who is HIV-negative and at substantial risk for HIV. Substantial risk includes:1. Anyone in an ongoing relationship with an HIV-positive partner2. Patients not in a mutually monogamous relationship with a partner who recently tested HIV-negative and is:

gay or bisexual man who had anal sex without using a condom or been diagnosed with an STD in the past six months or

heterosexual individual who does not regularly use condoms during sex with partners of unknown HIV status who are at substantial risk.

3. Individuals who have injected illicit drugs in the past six months and who have shared injection equipment or been in drug treatment of IV drug use in the past 6 months.

Appropriate Use of PrEP In May, 2014, the US Public Health Service made clinical recommendations regarding the implementation of PrEP for the prevention of HIV. They recommend that HIV infection be assessed at least every three months while patients are taking PrEP. This is so that individuals who contract the disease can be switched over to the appropriate therapy. Additionally, it decreases the likelihood of developing resistance. Renal function should be monitored upon initiation of the medication and rechecked every six months. If renal failure develops the drug should be discontinued.When PrEP is initiated patients should be provided access to proven effective risk reduction services. The efficacy of PrEP directly correlated with medication adherence. Understanding the realities of medication adherence, PrEP should be undergone in conjunction with other safe sex practices in the event that patients inconsistently take the medication.

Is it appropriate to prescribe HIV prevention medications from the emergency department? Truvada works and is recommended for specific populations. However, as an emergency medicine physician I’m left wondering what role, if any, it should have in my practice.

ED based HIV screening and targeted testing has been studied in the literature and applied by emergency departments across the country (5-8). Additionally, there is a cadre of information and CDC recommendations on how to address post exposure prophylaxsis (9, 10). However, the area of pre-exposure prophylaxsis is a new frontier and the literature is sparse.

As emergency medicine physicians we are conquerors of the acute. If you have dyspnea of unknown etiology, I’m the physician you want at your bedside. Acute onset of chest pain? I will mobilize the might of the appropriate specialists and diagnosticians to determine the cause and most effective treatment. However, ask me to adjust your blood pressure medications and I look more uncomfortable than Mel Gibson inside a Tabernacle. Approach me with recommendations on how to optimize your insulin regimen and my eyes glaze over as I daydream about securing a difficult airway or emergently placing a transvenous pacer.

Unfortunately, starting patients on PrEP is no different. As an ED doctor I do not have the capabilities to re-check your HIV status every three months or consistently follow your renal function. For these reasons, I can appreciate why emergency medicine physicians are hesitant to prescribe PrEP. However, these concerns do not absolve us from our responsibility to talk with patients about the benefits of PrEP.

PrEP and specifically Truvada, need to become commonplace in our discharge instructions for patients in whom we are concerned about high risk behavior. We have a captive audience and a responsibility to educate them about the ways that they can reduce their risk of contracting HIV. So much of what we do as emergency medicine physicians is reactionary. This is a chance to be proactive. In the same way that an aspirin reduce myocardial infarction risk, Truvada decreases HIV risk and we need to embrace PrEP as part of our nomenclature when educating patients.

Truvada is expensive and not all patients will be able to afford it. Become familiar with your local resources and identify clinics in your community where you can refer patients.

The Bottom Line

Truvada is the only drug approved for HIV PrEP.

PrEP significantly reduces the risk of acquiring HIV in those individuals who engage in high risk behavior.

Emergency medicine physicians need to inform those patients that engage in high risk behaviors about PrEP and how they can obtain preventative care.

Question to the FOAM community This is a controversial topic and a new area for emergency medicine. We would love to get your feedback and comments.

Is PrEP and Truvada something that you would initiate from the ED?

How do you handle patients who engage in high risk behaviors and would this be an option for them?

Smith DK, Grohskopf LA, Black RJ, et al. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005;54(RR-2):1-20.

Merchant RC. Update on emerging infections: news from the Centers for Disease Control and Prevention. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States. Ann Emerg Med. 2005;46(1):82-6.

This article/blog post is awesome! As stated above, Truvada and other antiretrovirals are recommended for those who have known contact with HIV positive partners and for those engaging in high risk activity. What I'm about to say is implied by the article, but I wanted to also make it really clear as a reminder for people that these medications should also be considered for victims of rape.

Reply

Sean Weaver

9/24/2014 06:10:46 am

Thanks for pointing out this out. While it may seem intuitive to start sexual assault victims on Truvada, this is not the recommendation of the CDC. Instead they state that sexual assault victims should be treated under the Post Exposure Prophylaxsis protocol guidelines and link the following for page for further information: http://www.cdc.gov/hiv/basics/pep.html.

Reply

Christopher Vader

3/20/2016 08:49:25 am

Thank you for addressing an issue of extreme importance. I was born in 1967 and, as a high school student, attended over 30 funerals one year. As a precocious youngster, I quite reasonably assumed that my own would be held soon.

When the ELISA test became available, I took a deep breath and went to the only place I could get one, our local medical school affiliated hospital. The wait for result was quite long and resulted in my first visit to an emergency department since my days as a frequent flyer in the laceration and broken bone days of childhood. I had a panic attack. I was not yet 21 and all of my mentors and role models were either dead or dying.

I was seen by a very young resident who I assumed would treat me as a pariah when I told him that I was gay and thought I might be either having a heart attack or a panic attack as I waited to get the news.

Instead, he treated me with what was true compassion (not yet having practiced long enough to really develop a good bedside manner). He tried to reassure me by telling me that somebody so young couldn't possibly have had enough exposure to be worried. When he got around to taking a good history, his eyes began to water and I found myself reassuring him that there were worse things than dying from Aids as a college sophomore. He sat with me for the longest time and sent me home with a prescription for enough benzos to keep me comatose until.the fateful date when the test would come back.

He also told me that if I miraculously dodged the bullet that I would have a duty to all of those who didn't. And, as in McArthur's address to the Corps, that I should expect a long rainbow line to rise from their Graves haunt me and whisper in my ear should I fail. That is why I write to you now.

That young man profoundly altered the course of my life not with pressors, or a Miller blade, but with his words.

Every postpubescent patient of yours should given a rapid antibody test and referred for treatment if positive. If not they should be counseled about prevention and many should be aggressively directed to followup with a practitoner who can start Truvada. If that were the protocol, the new infection rate would be dramatically impacted.

Thank you for taking time away from Miller blades and pressors to think a bit about the part the ED can play in the final act of what was, for my generation, a modern plague.

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